Cytotech Antinuclear Antibody (Ana) Ifa Kit

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K871801 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Antinuclear Antibody (Ana) Positive Controls

  Class II

  FDA 510(k) K873249 Active Cleared 22 Sep 1987

• Cytotech Hsv Igg Enzyme Immunoassay

  Class II

  FDA 510(k) K862838 Active Cleared 9 Dec 1986

• Cytotech Rubella Igg Enzyme Immunoassay

  Class II

  FDA 510(k) K864315 Active Cleared 2 Feb 1987

• Circulating Immune Complexes Controls

  Class II

  FDA 510(k) K882829 Active Cleared 4 Aug 1988

• Cytotech C1-Inhibitor Enzyme Immunoassay Open recall

  Class II

  FDA 510(k) K872426 Active Cleared 23 Jul 1987

• Cic-Raji Cell Replacement Enzyme Immunoassay

  Class II

  FDA 510(k) K874379 Active Cleared 25 Nov 1987

See all devices from Cytotech, Inc. →